1. James Tattersall European Best Practice Guidelines

2. Background Process commissioned by EDTA-ERA in 1998 KDOQI, CARI, UK renal guidelines already published Considerable guideline activity underway “Expert groups” Transplant (2000, 2002) HD (2002, 2007) PD (2005) Anaemia (1999, 2005)

3. Co-operative initiatives K/DOQI Bone metabolism 2004 Hypertension in CKD 2004 CVD in dialysis 2005 Anemia 2006 KDIGO Classification/ definition CKD Hep C Bone/mineral metabolism

4. Organisation facilitating guidelines Logistical and secretarial Baxter Fresenius Hoffman-La Roche, Amgen, Vifor, Ortho-Biotech Literature search and evidence grading Cochrane (HD) Thomson Gardiner-Caldwell (Anaemia) Collection of feedback and dissemination of guidelines EDTA-ERA

5. Funding sources Baxter (PD) Fresenius (HD) Hoffman-La Roche (Transplant, Anaemia) Amgen (Anaemia) Ortho Biotech (anaemia) Vifor (anaemia)

6. How guidelines relate to healthcare systems in area Europe is diverse 30 + countries Mixture of models (socialised, insurance-based) Mixture of languages. Differences between levels in healthcare funding. ‘New’ ex-soviet empire European countries inherited broken systems. At least for dialysis, convergence was surprisingly rapid. No attempt to include cost-benefit in the guidelines

7. Selection and prioritisation of guideline topics No formal process Decided by the expert groups (HD, PD, Transplant) Composition of group Existing guidelines Availability of evidence Considered to be important

8. Selection of expert groups Invited by the ERA-EDTA council. No formal selection process European experts on the guideline topic No more than 1-2 per country in each group. Initially only nephrologists HD group invited one dietician, one radiologist and one surgeon for 2 nd part.

9. Methodology Delegated to expert groups. Division into sub-groups (3-4 members) Formulation of important questions Generation of key words Literature search performed by Cochrane All literature graded by Cochrane All literature scored by expert group. Each paper scored by at least 2 members. Modified READER system (with elements of GRADE) used to score papers.

10. Methodology (2) Randomly selected papers presented to group and the scores challenged by whole group. Low-scoring papers automatically rejected Reader score includes relevancy. Rejected papers retained as part of the guideline audit. Guidelines formulated by sub-groups. Guidelines presented and circulated to entire group. All guidelines signed-off by each group member.

11. Methodology (3) External expert reviewers selected Non-nephrologists Non-European Draft guidelines submitted to Reviewers ERA-EDTA membership Selected international nephrology societies (ISN, ASN, CSN, CARI) All European national associations.

12. Disseminations and implementation Draft guidelines, responses and proposed amendments presented at ERA-EDTA conference 2006 Final versions published 2007 Published in NDT ERA-EDTA website Impact to be assessed by QUEST projects. Adequacy of HD

13. strengths Formal, independent selection of evidence. Formal, transparent scoring of papers. Consultation at late stages Ongoing study to assess impact (QUEST) weaknesses Commercial funding Qualification/selection of expert groups. No patient, manager or nurse representation. Inconsistent style, format, terminology No consideration of guideline lifecycle No consultation at early stage Prioritisation Questions asked What the guidelines are trying to achieve not clearly stated.

14. Future outlook ERA-EDTA have a responsibility to maintain, update, withdraw or correct existing guidelines. Impact of existing guidelines to be monitored by QUEST ERA-EDTA council have decided that the Association should remain involved in new guideline development. The form of this involvement has not yet been decided. First EBPG meeting January 2008